This invention relates to a system and method for emplacing a repair device within a patient's vasculature and, more particularly, to a delivery catheter and method of use for placement within a corporeal lumen of a tapered graft having one or more attachment systems.
It is well established that various fluid conducting body or corporeal lumens, such as veins and arteries, may deteriorate or suffer trauma so that repair is necessary. For example, various types of aneurysms or other deteriorative diseases may affect the ability of the lumen to conduct fluids and in turn may be life-threatening. In some cases, the damaged lumen is repairable only with the use of prosthesis such as an artificial vessel or graft.
For repair of vital vessels such as the aorta, surgical repair is significantly life-threatening. Surgical techniques known in the art involve major surgery in which a graft resembling the natural vessel is spliced into the diseased or obstructed section of the natural vessel. Known procedures include surgically bypassing the damaged or diseased portion of the vessel and inserting an artificial or donor graft attached to the native vessel by an anastomosis.
It is also known within the art to provide a repair device or prosthesis for intraluminal repair of a vessel, such as an abdominal aorta having an aneurysm. The art has taught to provide a prosthesis positioned in a vessel then securing the prosthesis within the vessel with hooks or staples that are mechanically extended by the user. The early prior art devices were large in diameter, mechanically complex and in turn were susceptible to mechanical failure. Prior intraluminal grafting systems have embodied capsule catheters or balloon catheters, but were relatively stiff and of a relatively high profile. Similarly, the prior art systems were configured in such a way that the graft was relatively difficult to deploy in the correct position. In addition, prior systems having a capsule catheter assembly were usually configured such that the prosthesis was disposed within a unitary capsule. Further, the prior prostheses were sometimes ill suited to withstand the high pressures existing in the vessels and, consequently, experienced structural failures.
Where the deteriorative disease occurs near a bifurcation, conventional tube and bifurcated grafts often cannot be used to repair the site. There may be insufficient room to implant an inferior end of a conventional tube graft near the bifurcation. Additionally, one branch of the bifurcation could be so diseased that a leg of a conventional bifurcated graft may be too large or small so that implant is impossible. Also, one branch of the bifurcation can be so diseased that blood through that branch should be blocked entirely and a different route provided.
Generally speaking, intraluminal repair of vessels or body lumens, where it is a viable alternative, can be performed with less threat to a patient. Moreover, since intraluminal repair does not require major surgery, the recovery time from such a procedure is usually shorter. However, in order to fully take advantage of the benefits of an intraluminal repair procedure, the system for accomplishing the same must be optimized to efficiently and effectively place a prosthesis within the vessel or lumen and include component parts which can be utilized in the situation where one branch of a bifurcation is so diseased that it is desirable to block it and provide an alternative route for blood flow through other surgical techniques such as a bypass. Furthermore, the prosthesis itself must be optimally configured so that it can withstand and adapt to the environment in which it is placed, as well as be specially equipped to repair a patient's vasculature near a diseased bifurcation. Accordingly, there is a need for the system to be configured such that advancement and deployment of the prosthesis and any auxiliary component parts can be accomplished in an efficient manner and such that the prosthesis can be accurately placed so that the attempted repair is effective. Additionally, there is a need for a prosthesis which itself is specifically configured for the environment existing within the vessel or lumen in which it is placed. Moreover, there exists a need for a grafting system which repairs diseased vessels in the situation where conventional tube and bifurcated grafts are found lacking. The present invention addresses these needs.
To provide consistency with the common usage of terms used in the medical surgical arts in the United States, the terms "proximal, distal, inferior and superior" are used with a certain regularity within the present specification. Proximal refers to parts of the system, such as catheters, capsules and wires, which are closest to the user and closest to the portion of the system outside or exterior of the patient. Distal refers to the point farthest from the user and typically most interior to the corporeal lumen. The term superior refers to a location situated above and is used herein in description of the graft and attachment system as well as the components of the delivery system. Inferior refers to the point situated below and again is used herein with the graft, attachment system and delivery system. Thus, for applications in the abdominal aorta which use a femoral approach, the superior end of the graft resides within the most distal or superior portion of the delivery catheter. Likewise, the inferior end of the graft resides within the inferior or proximal capsule which is on the most distal or superior portion of the capsule catheter.
The term "ipsilateral" typically refers to a vessel or part of a device which resides on the same side in which a device enters a lumen. Similarly, the term "contralateral" refers to a vessel or device residing on the opposite side of which the main device enters, for example, the iliac or femoral arteries.